Inhaled Ciclesonide for Outpatients With COVID19

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

215 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-15

Study Completion Date

2021-07-08

Brief Summary

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The CONTAIN (CiclesOnide cliNical TriAl covId-19 treatmeNt) is a randomized control study of ciclesonide vs placebo for mild covid-19 disease. The need for potential therapy for COVID-19 patients is urgent. Ciclesonide has shown encouraging in vitro results, is easy to be used and is readily available. It has a low rate of side effects and few interactions with other drugs. It is unusual to use an inhaled steroid drug for COVID-19 but there has been new data suggesting steroids may have an antiviral effect in addition to an anti-inflammatory effect. Investigators propose to use inhaled and nasal ciclesonide to stop viral replication in the nose and airways. Investigators hope this will accelerate recovery from COVID-19 illness in individuals who are not admitted to hospital at time of diagnosis of COVID-19.

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Detailed Description

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Conditions

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COVID 19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Ciclesonide inhaled and nasal

Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days

Group Type ACTIVE_COMPARATOR

Ciclesonide

Intervention Type DRUG

Ciclesonide 600mcg BID inhaled with aero chamber

Ciclesonide nasal

Intervention Type DRUG

intranasal ciclesonide 200 mcg DIE

Placebo

Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID

Group Type PLACEBO_COMPARATOR

Normal Saline intranasal and placebo inhaler

Intervention Type DRUG

Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID

Interventions

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Normal Saline intranasal and placebo inhaler

Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID

Intervention Type DRUG

Ciclesonide

Ciclesonide 600mcg BID inhaled with aero chamber

Intervention Type DRUG

Ciclesonide nasal

intranasal ciclesonide 200 mcg DIE

Intervention Type DRUG

Other Intervention Names

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Alvesco Omnaris

Eligibility Criteria

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Inclusion Criteria

Symptomatic adult patients positive by PCR for COVID-19 within 5 days of enrollment with fever, cough, or shortness of breath. Provision of Informed Consent

At day 0, patients should be at home

Exclusion Criteria

* Already on inhaled corticosteroid medication
* Currently using systemic steroids (oral or intravenous or intramuscular such as Prednisone) or use of steroids 7 days prior to enrolment
* Severely ill patients at enrollment (i.e., admitted to ICU at admission)
* Unable to self-administer the inhaler
* Known or suspected pregnancy and breastfeeding
* Known allergy to study medication or its components (non-medicinal ingredients; including lactose allergy (type I))
* Patients with untreated fungal, bacterial, or tubercular infections of the respiratory tract
* Current hospitalization
* Current use of oxygen at home or in the hospital

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No